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NCT Number: NCT06243887

Implementing Enhanced Recovery After Surgery (ERAS) Protocol in Patients Undergoing Minimal Invasive Esophagectomy

Detect impact of enhanced recovery after surgery (ERAS) on the outcomes of oesophageal surgery .

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Key information

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

esophagectomy for both malignant and benign disease has been identified as a particularly complex surgical procedure due to documented high levels of peri-operative morbidity and mortality.

A comprehensive review of complications associated with the esophagectomies performed in high-volume esophageal units utilizing a standardized format for documenting complications and quality measures has confirmed an overall complication rate of 59 % with 17.2% of patients sustaining complications of IIIb or greater utilizing the Clavien-Dindo severity grading system. post-operative complications include high rate of anastomotic leakage , pulmonary infection ,thoracic duct injury , voice changes , breathlessness ,long hospital stay.

These outcomes accentuate the need for providing an enhanced recovery after surgery standardized format for esophagectomy which can be routinely applied and audited to improve international outcomes. though ERAS lacking randomized control trials

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1) first detected and endoscopically confirmed esophageal cancer; 2)preoperative evaluation showed no distant metastases and suitable for MIE; 3preoperative clinical stage of I to III

Exclusion criteria

  • 1) patients had a history of thoracic or abdominal surgery; 2)patients were IV to VI in the American Society of Anesthesiologists (ASA) physical status classification system; 3)patients had other malignancies; 4)patients had missing clinical data

Treatment and study plan

Enhanced Recovery After Surgery (ERAS) protocol in minimal invasive esophagectomy

Other

Enhanced Recovery After Surgery (ERAS) refers to patient-centered, evidence-based, multidisciplinary team developed pathways for a surgical specialty and facility culture to reduce the patient's surgical stress response, optimize their physiologic function, and facilitate recovery.

standard of care approaches in minimal invasive esophagectomy

Other

standard of care approaches other than ERAS

Primary outcomes

  1. Enhanced recovery after surgery (ERAS)

    Time frame: average 2 years

    Detect impact of enhanced recovery after surgery on the outcomes of oesophageal surgery concerning

    • time to out-of-bed activity
    • time to first flatus
    • time to liquid diet
    • postoperative hospital stay
    • ICU length of stay
    • ICU length of stay
    • in-hospital mortality
    • incidence of various postoperative complications

Secondary outcomes

  1. Enhanced recovery after surgery (ERAS)

    Time frame: average 2 years

    Detect impact of enhanced recovery after surgery on the outcomes of oesophageal surgery concerning

    1)postoperative chest drainage volume

Study contacts

Contact information is provided by the study sponsor or research team.

Khaled Hussein, master

CONTACT

[email protected]

+201098315303

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2024
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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